European Medicines Agency Widens Public Access to Documents

Policy on access to documents also sets out new approach for
proactive disclosure of documents

The European Medicines Agency (EMA) has published its new policy
on access to documents related to medicines for human and
veterinary use. The new policy is part of the Agency’s
response to increasing public demand for more openness and
transparency. It will give wider access than ever before to
documents held by the Agency, while it ensures that personal data
and commercial confidential information remain adequately
protected.

“Openness and transparency are enshrined as fundamental
values in the Agency’s regulatory framework”, says
Noël Wathion, Head of Patient Health Protection at the
European Medicines Agency. “They allow our stakeholders to
understand the basis for the Agency’s scientific
decision-making and provide for the basis on which patients and
healthcare professionals can have confidence in our opinions and
information relating to medicines.”

As a general rule, the Agency will release documents once a
procedure concerning a medicine has been finalised to protect the
decision-making process.

The new policy gives access to all business-related documents
unless there is a need to respect arrangements with non-EU
regulators or international organisations, or to protect the
privacy and integrity of a natural or legal person. Documents
submitted to the Agency as part of a marketing authorisation
application, such as clinical trial reports, can now also be
released, provided the decision-making process for the application
in question is finalised. Where only parts of a document contain
information that cannot be disclosed, the Agency will redact the
document to protect personal data and commercial confidential
information, and release the non-confidential parts.

The Agency has produced general guidance on the types of
documents it holds, whether they can be made available and whether
they will have to be redacted. The list in form of an ‘output
table’ is available on the Agency’s website.

Implementation of the policy will be in a two-step approach. The
first phase will focus on reactive disclosure of documents in
response to written requests. During this phase the Agency will put
in place arrangements to ensure that implementation of this new
policy will not conflict in any way with the ability of the Agency
to perform its core functions of authorisation and supervision of
medicines. In the second phase, the Agency will gradually populate
the electronic register with documents held by the Agency which can
be disclosed.

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